The Pharmaceutical Journal
Vol 271 No 7256 p9
5 July 2003

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Osteoporosis drugs go head to head

Head-to-head data on osteoporosis treatments were released at the National Osteoporosis Society conference in Bath last week.

Most prominent were the results from the EFFECT trial comparing alendronate (Fosamax) with raloxifene (Evista) which suggested alendronate has over twice the effect on bone density. Another trial failed to show any difference between raloxifene and risedronate (Actonel).

EFFECT (efficacy of Fosamax versus Evista comparison trial) looked at 487 post-menopausal women randomised to receive 70mg alendronate once weekly or 60mg raloxifene daily. After a year, bone mineral density (BMD) of the lumbar spine increased by 4.8 per cent for those receiving alendronate compared with 2.2 per cent for those receiving raloxifene (P<0.001) and total hip BMD went up by 2.3 per cent versus 0.8 per cent, respectively (P<0.001).

Overall tolerability was similar for the two treatments although 16 per cent of patients reported drug-related upper GI side effects with raloxifene compared with 9 per cent taking alendronate (P=0.029)

Presenting the results, Dr Peter Selby, consultant physician at Manchester Royal Infirmary, said: "There's an obvious and clinically relevant difference between these two treatments. While relying on BMD data isn't ideal, it seems unlikely we'll ever get trials of sufficient power to demonstrate fracture differences between osteoporosis treatments."

Data from a UK retrospective study comparing raloxifene with risedronate in 93 patients were also presented but the results failed to show a difference between the two treatments. Patients received 60mg raloxifene daily or 5mg risedronate daily. Repeat scans showed no significant improvement in BMD in either group.

The authors say the small number of patients involved in the trial could account for the results. Furthermore, the mean age of this group of patients, at 66 years, was much lower than in previous larger trials.

Data from a third trial, comparing alendronate with teriparatide, was also presented. Teriparatide is an recombinant bone formation treatment while alendronate is an antiresorptive agent.

After six months lumbar spine BMD was 4.7 per cent higher in the teriparatide group compared with 3.2 per cent in the alendronate group (P<0.01). Teriparatide is expected to be launched in the UK this year.